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  1. Article ; Online: Sharing data among clinical trials of therapeutics in COVID-19

    Marisha E. Palm / Christopher J. Lindsell / Harry P. Selker

    Journal of Clinical and Translational Science, Vol

    Barriers and facilitators to collaborating in a crisis

    2022  Volume 6

    Abstract: Abstract Background: The Clinical and Translational Science Award Program (CTSA) Trial Innovation Network (TIN) was launched in 2016 to increase the efficiency and effectiveness of multisite trials by supporting the development of national infrastructure. ...

    Abstract Abstract Background: The Clinical and Translational Science Award Program (CTSA) Trial Innovation Network (TIN) was launched in 2016 to increase the efficiency and effectiveness of multisite trials by supporting the development of national infrastructure. With the advent of the COVID-19 pandemic, it was therefore well-positioned to support clinical trial collaboration. The TIN was leveraged to support two initiatives: (1) to create and evaluate a mechanism for coordinating Data and Safety Monitoring Board (DSMB) activities among multiple ongoing trials of the same therapeutic agents, and (2) to share data across clinical trials so that smaller, likely underpowered studies, could be combined to produce meaningful and actionable data through pooled analyses. The success of these initiatives was understood to be dependent upon the willingness of investigators, study teams, and US National Institutes of Health research networks to collaborate and share information. Methods: To inform these two initiatives, we conducted semistructured interviews with members of CTSA hubs and clinical research stakeholders that probed barriers and facilitators to collaboration. Thematic analysis identified topics relevant across institutions, individuals, and DSMBs. Results: The DSMB coordination initiative was viewed as less controversial, while the data pooling initiative was seen as complex because of its potential impact on publication, authorship, and the rewards of discovery. Barriers related to resources, centralization, and technical work were significant, but interviewees suggested these could be handled by the provision of central funding and supportive frameworks. The more intractable findings were related to issues around credit and ownership of data. Conclusion: Based on our interviews, we conclude with nine recommended actions that can be implemented to support collaboration.
    Keywords COVID-19 ; Trial Innovation Network ; CTSA ; clinical trials ; DSMB ; data sharing ; collaboration ; Medicine ; R
    Subject code 001
    Language English
    Publishing date 2022-01-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: The continued evolution of team science

    Harry P. Selker

    Journal of Clinical and Translational Science, Vol 1, Pp 7-

    2017  Volume 7

    Keywords Medicine ; R
    Language English
    Publishing date 2017-02-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: Pilot test of an accrual Common Metric for the NIH Clinical and Translational Science Awards (CTSA) Consortium

    Denise H. Daudelin / Laura E. Peterson / Harry P. Selker

    Journal of Clinical and Translational Science, Vol

    Metric feasibility and data quality

    2021  Volume 5

    Abstract: Failure to accrue participants into clinical trials incurs economic costs, wastes resources, jeopardizes answering research questions meaningfully, and delays translating research discoveries into improved health. This paper reports the results of a ... ...

    Abstract Failure to accrue participants into clinical trials incurs economic costs, wastes resources, jeopardizes answering research questions meaningfully, and delays translating research discoveries into improved health. This paper reports the results of a pilot test of the Median Accrual Ratio (MAR) metric developed as a part of the Common Metrics Initiative of the NIH’s National Center for Advancing Translational Science (NCATS) Clinical and Translational Science Award (CTSA) Consortium. Using the metric is intended to enhance the ability of the CTSA Consortium and its “hubs” to increase subject accrual into trials within expected timeframes. The pilot test was undertaken at Tufts Clinical and Translational Science Institute (CTSI) with eight CTSA Consortium hubs. We describe the pilot test methods, and results regarding feasibility of collecting metric data and the quality of data that was collected. Participating hubs welcomed the opportunity to assess accrual efforts, but experienced challenges in collecting accrual metric data due to insufficient infrastructure and inconsistent implementation of electronic data systems and lack of uniform data definitions. Also, the metric could not be constructed for all trial designs, particularly those using competitive enrollment strategies. We offer recommendations to address the identified challenges to facilitate progress to broad accrual metric data collection and use.
    Keywords Performance improvement ; common metrics ; translational science ; study accrual ; CTSA ; Medicine ; R
    Subject code 310
    Language English
    Publishing date 2021-01-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Participant and research team perspectives on the conduct of a remote therapeutic COVID-19 clinical trial

    Denise H. Daudelin / Sarah K. Brewer / Alyssa B. Cabrera / Dorothy Dulko / Harry P. Selker

    Journal of Clinical and Translational Science, Vol

    A mixed methods approach

    2022  Volume 6

    Abstract: Abstract Background: Responding to the need to investigate potential treatments of COVID-19, a research team employed a telehealth platform to determine whether niclosamide, an oral anthelmintic drug that had shown antiviral activity, reduced SARS-CoV-2 ... ...

    Abstract Abstract Background: Responding to the need to investigate potential treatments of COVID-19, a research team employed a telehealth platform to determine whether niclosamide, an oral anthelmintic drug that had shown antiviral activity, reduced SARS-CoV-2 shedding and duration of symptoms in patients with mild-to-moderate symptoms of COVID-19. To encourage compliance with patient self-quarantine, this randomized placebo-controlled clinical trial was conducted utilizing a remote telehealth design to complete all study visits, monitor symptoms, and coordinate participant self-collected specimens. Methods: A mixed methods approach employing surveys and interviews of trial participants and interviews of research team members was used to collect their experiences with and perspectives on the acceptability of the remote clinical trial design and delivery. Results: Of the 67 eligible trial participants invited to take part in a study to evaluate the telehealth platform, 46% (n = 31) completed a post-participation survey. While 97% (n = 30) of respondents had not previously participated in a clinical trial, 77% (n = 24) reported they would consider taking part in a future remote research study. The majority of respondents were moderately or very comfortable (93%) with using the technology. Conclusions: The COVID-19 crisis was a call to action to expand understanding of the conduct of remote clinical trials, including the experiences of research participants. Our findings showed that this approach can be both effective for the conduct of research and positive for participants. Further research on the use of telehealth research platforms seems warranted in rural, underserved populations, and remote trials of prevention, screening, and treatment.
    Keywords Remote clinical trial ; COVID-19 ; research participant experience ; Medicine ; R
    Subject code 310
    Language English
    Publishing date 2022-01-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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    Inter-library loan at ZB MED

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  5. Article ; Online: Changing the incentives for development of low-cost high-impact treatments

    Harry P. Selker / Herbert Pardes

    Journal of Clinical and Translational Science, Vol 1, Pp 267-

    2017  Volume 268

    Keywords Medicine ; R
    Language English
    Publishing date 2017-10-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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    Inter-library loan at ZB MED

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  6. Article ; Online: Pilot test of an accrual Common Metric for the NIH Clinical and Translational Science Awards (CTSA) Consortium

    Laura E. Peterson / Denise H. Daudelin / Lisa C. Welch / Anshu Parajulee / Harry P. Selker

    Journal of Clinical and Translational Science, Vol

    Metric usefulness

    2021  Volume 5

    Abstract: The Common Metrics Initiative aims to develop and field metrics to improve research processes within the national Clinical and Translational Science Award (CTSA) Consortium. A Median Accrual Ratio (MAR) common metric was developed to assess the results ... ...

    Abstract The Common Metrics Initiative aims to develop and field metrics to improve research processes within the national Clinical and Translational Science Award (CTSA) Consortium. A Median Accrual Ratio (MAR) common metric was developed to assess the results of efforts to increase subject accrual into a set of clinical trials within the expected time period. A pilot test of the MAR was undertaken at Tufts Clinical and Translational Science Institute (CTSI) with eight CTSA Consortium hubs. Post-pilot interviews were conducted with 9 CTSA Principal Investigators (PIs) and 23 pilot team members. Over three-quarters (78%) of respondents reported that the MAR could be useful for performance improvement, but also described limitations or concerns. The most commonly cited barrier to MAR use for performance improvement was difficulty in interpreting the single value that is produced. Most respondents were interested in using the MAR to assess recruitment at an individual trial level. Majority of respondents (63%) had mixed opinions about aggregating metric results across the CTSA Consortium for comparison or benchmarking. Collecting data about additional contextual factors, and comparing accrual between subgroups, were cited as potentially helping address concerns about aggregation. Significant challenges remain in ensuring that the MAR can be sufficiently useful for collaborative process improvement. We offer recommendations to potentially improve metric usefulness.
    Keywords Performance improvement ; common metrics ; translational science ; study accrual ; CTSA ; Medicine ; R
    Subject code 310
    Language English
    Publishing date 2021-01-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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    Inter-library loan at ZB MED

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  7. Article ; Online: Maintenance efficacy designs in psychiatry

    S. N. Ghaemi / Harry P. Selker

    Journal of Clinical and Translational Science, Vol 1, Pp 198-

    Randomized discontinuation trials – enriched but not better

    2017  Volume 204

    Abstract: Introduction Although classical randomized clinical trials (RCTs) are the gold standard for proof of drug efficacy, randomized discontinuation trials (RDTs), sometimes called “enriched” trials, are used increasingly, especially in psychiatric maintenance ...

    Abstract Introduction Although classical randomized clinical trials (RCTs) are the gold standard for proof of drug efficacy, randomized discontinuation trials (RDTs), sometimes called “enriched” trials, are used increasingly, especially in psychiatric maintenance studies. Methods A narrative review of two decades of experience with RDTs. Results RDTs in psychiatric maintenance trials tend to use a dependent variable as a predictor: treatment response. Treatment responders are assessed for treatment response. This tautology in the logic of RDTs renders them invalid, since the predictor and the outcome are the same variable. Although RDTs can be designed to avoid this tautologous state of affairs, like using independent predictors of outcomes, such is not the case with psychiatric maintenance studies Further, purported benefits of RDTs regarding feasibility were found to be questionable. Specifically, RDTs do not enhance statistical power in many settings, and, because of high dropout rates, produce results of questionable validity. Any claimed benefits come with notably reduced generalizability. Conclusions RDTs appear to be scientifically invalid as used in psychiatric maintenance designs. Their purported feasibility benefits are not seen in actual trials for psychotropic drugs. There is warrant for changes in federal policy regarding marketing indications for maintenance efficacy using the RDT design.
    Keywords Enriched ; randomized discontinuation ; maintenance ; clinical trials ; psychotropic drugs ; Medicine ; R
    Subject code 310
    Language English
    Publishing date 2017-06-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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    Inter-library loan at ZB MED

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  8. Article ; Online: From community engagement, to community-engaged research, to broadly engaged team science

    Harry P. Selker / Consuelo H. Wilkins

    Journal of Clinical and Translational Science, Vol 1, Pp 5-

    2017  Volume 6

    Abstract: A foundational principle and practice for translational research is active participation of a range of disciplines, referred to as “team science.” It is increasingly apparent that to be relevant and impactful, these teams must also include stakeholders ... ...

    Abstract A foundational principle and practice for translational research is active participation of a range of disciplines, referred to as “team science.” It is increasingly apparent that to be relevant and impactful, these teams must also include stakeholders outside the usual academic research community, such as patients, communities, and not-for- and for-profit organizations. To emphasize the need to link the practices of team science and of community-engaged research, we propose a framework that has community members and stakeholders as integral members of the research team, which we term, “broadly engaged team science.” Such transdisciplinary and multi-stakeholder teams will be best suited to pose translational research questions, conduct the research, and interpret and disseminate the results. We think this will generate important and impactful science, and will support the public’s regard for, and participation in, research.
    Keywords Medicine ; R
    Subject code 306
    Language English
    Publishing date 2017-02-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  9. Article ; Online: Certification of clinical and translational researchers

    Paul R. Marantz / Harry P. Selker / Emma A. Meagher

    Journal of Clinical and Translational Science, Vol 1, Pp 3-

    An ill-conceived notion

    2017  Volume 4

    Abstract: Abstract The National Board of Medical Examiners (NBME) has instituted a new multiple choice examination in order to “certify” clinical and translational investigators. As experienced research educators, we argue that this certification process is ... ...

    Abstract Abstract The National Board of Medical Examiners (NBME) has instituted a new multiple choice examination in order to “certify” clinical and translational investigators. As experienced research educators, we argue that this certification process is unnecessary, values knowledge over competency, may be counter-productive, and is unlikely to achieve any worthwhile outcome. We lay out these arguments in the hope of stimulating a robust discussion among leaders, faculty, and learners engaged in clinical research education and training.
    Keywords Medicine ; R
    Language English
    Publishing date 2017-02-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  10. Article ; Online: Response of the trial innovation network to the COVID-19 pandemic

    Rachel G. Greenberg / Lori Poole / Daniel E. Ford / Daniel Hanley / Harry P. Selker / Karen Lane / J. Michael Dean / Jeri Burr / Paul Harris / Consuelo H. Wilkins / Gordon Bernard / Terri Edwards / Daniel K. Benjamin

    Journal of Clinical and Translational Science, Vol

    2021  Volume 5

    Abstract: Abstract Introduction: The COVID-19 pandemic prompted the development and implementation of hundreds of clinical trials across the USA. The Trial Innovation Network (TIN), funded by the National Center for Advancing Translational Sciences, was an ... ...

    Abstract Abstract Introduction: The COVID-19 pandemic prompted the development and implementation of hundreds of clinical trials across the USA. The Trial Innovation Network (TIN), funded by the National Center for Advancing Translational Sciences, was an established clinical research network that pivoted to respond to the pandemic. Methods: The TIN’s three Trial Innovation Centers, Recruitment Innovation Center, and 66 Clinical and Translational Science Award Hub institutions, collaborated to adapt to the pandemic’s rapidly changing landscape, playing central roles in the planning and execution of pivotal studies addressing COVID-19. Our objective was to summarize the results of these collaborations and lessons learned. Results: The TIN provided 29 COVID-related consults between March 2020 and December 2020, including 6 trial participation expressions of interest and 8 community engagement studios from the Recruitment Innovation Center. Key lessons learned from these experiences include the benefits of leveraging an established infrastructure, innovations surrounding remote research activities, data harmonization and central safety reviews, and early community engagement and involvement. Conclusions: Our experience highlighted the benefits and challenges of a multi-institutional approach to clinical research during a pandemic.
    Keywords Trial innovation network ; COVID-19 ; clinical trial ; SARS-CoV-2 ; CTSA ; Medicine ; R
    Language English
    Publishing date 2021-01-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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